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A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

NCT01024036 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2018-03-21

Study results available
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Summary

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

Conditions

  • Multicentric Castleman's Disease

Interventions

DRUG

Siltuximab

Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks

DRUG

Placebo

Placebo will be administered by 1-hour intravenous infusion every 3 weeks

DRUG

Best Supportive Care (BSC)

BSC included treatment for effusions, antipyretics, antipuretics, antihistamines, pain medication, treatment for infections, transfusions, management of infusion-related reactions, and corticosteroids.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-18
Primary Completion
2013-03-25
Completion
2017-02-24

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Egypt
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Malaysia
  • Netherlands
  • New Zealand
  • Norway
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024036 on ClinicalTrials.gov